cobas SARS-CoV-2 & Influenza A/B Test for use on the recall
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Why was cobas SARS-CoV-2 & Influenza A/B Test for use on the recalled?
Customers have reported an increased number of false positive SARS-CoV-2 results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 10119Z
- Product
- cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 211 kits (US); 3073 kits (OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)